Ethical Guidelines

OriginsThree Historical Precedents for Current Scientific Research

Guidelines

Nuremburg Code:

Result of war crimes trials for Nazi scientiststhose convicted were the only
people ever executed by Israel;
Experiments were conducted on concentration camp detaineesno previous
rules/guidelines against;
3 main contributorsLeo Alexander (chief med. Advisor for prosecution)
contributors started with Hippocratic Oath, but felt it didnt cover human
rights enoughneeded to extend ethical guidelines to scientific researchers
utilized military guidelines for treatment of war detainees;
o Code Include 10 main points
First international doc to advocate for Voluntary and Informed
consentlots of questions regarding informed consent
Experiment yields fruitful results for good of society
Experiment on animals first
Avoid unnecessary physical suffering and injury
No apriori reason to presume death or disability
Risks should not exceed humanitarian importance of the
problem to be resolved
Proper preparations and adequate facilities provided to protect
subjects
Conducted by scientific experts
Subject may end participation if the burden is too great
Scientist must be prepared to end experiment if it seems like
harm could come to subject
o Provided basis for Japanese war crimes trial during same time period,
genocides in Yugoslavia and Rwanda
Currently (2000) being challenged with regards to embryonic research;
Experiments included gasing of French detainees (paradoxhis research was
later used to write guidelines for working with the gas); also mustard gas
experiments paved way towards chemotherapy
Lead to World Medical Associationnot all researchers followed these codes
had to be refined with later ethical guidelines

Declaration of Helsinki:

Adopted in June, 1964

o Has since been revised 7 times. Most recent 2013

Declares that the researcher must provide informed consent
Lead to GCPethical and scientific quality standards regarding designing,
conducting, recording, and reporting trials of human subject research. Public
assurance that trial subjects are being protected
Sets basis for human subject approval process. Designed to maximize
benefits and minimize harms.
Protects basic identity and social information
Inspired by Nuremburg trials

Belmont:

Origin: Experiment to better understand syphilis (600 African American men)

o 399 previously had syphilis
o Were promised free health care (not provided)
o Even after cure for syphilis was developed, research subjects were not
administered the cure;
o Wives and children of these men contracted syphilis because men
were not informed that they were affected by syphilis;
BeneficenceThe benefits of the experiment outweigh risksdo no harm to
subjects
o Strengthened the Hippocratic Oath
Voluntary, Informed Consent
o No children or mentally handicapped persons can opt in without a
guardians consent
o Equal selectionneed to have heterogeneous participant pool
Research subjects within the Tuskegee Syphilis Research compared to victims
of concentration camps
Report created 3 refined principles
o Respect people as autonomous beings
o No harm, maximize benefits (beneficence)
o Participants should be equally, and fairly compensated